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ACTIVE NOT RECRUITING
NCT06872359
NA

Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

Sponsor: Kiomed Pharma

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. The main questions it aims to answer are: If the products are safe \- Acceptable local tolerance, with acceptable clinical signs after injection. If the clinical performance is as intended compared to baseline * Evaluation of performance by assessing the improvement of the appearance of the defect to be corrected by using Global Aesthetic Improvement Scale (GAIS) * Quantification of the improvement using the appropriate scale when available or other appropriates tool (angle for chin, for instance). * Pain felt during injection and after injection * Subject satisfaction

Official title: Prospective, Multicentric, Open Label Clinical Investigation to Evaluate Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2025-03-25

Completion Date

2027-09

Last Updated

2025-09-08

Healthy Volunteers

Yes

Interventions

DEVICE

KIO017-1

Subcutaneous and/or supraperiostal injections in chin and/or mid-face and/or jawline. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

DEVICE

KIO017-2

Subcutaneous injections in temples and/or nasolabial folds and/or marionette lines and/or mid-face. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

DEVICE

KIO017-3

Injections in or around labial mucosa for lip volume and contour and/or intradermal injections in perioral lines. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

Locations (3)

Eurofins Dermscan Pharmascan

Aix-en-Provence, France

Eurofins Dermscan Pharmascan

Villeurbanne, France

Centrum Medyczne "Tu Sie Leczy"

Gdansk, Poland